NCT01062477

A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants

Safety and Immunogenicity of the Sanofi Pasteur's DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Hib Conjugate (Act-HIB) Monovalent Vaccine as a Three-dose Primary and Booster Vaccination in Healthy Infants in China

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,056 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 60 Days – 89 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined vaccine in support of registration of this product in China Primary Objectives: * To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria, Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP) antigens, one month after the three-dose primary vaccination. * To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose primary vaccination. Secondary Objectives: * To describe the safety after administration of the study vaccines. * To describe in each group the immunogenicity of the study vaccines one month after the primary vaccination and before and one month after the booster vaccination.

Detailed description

Participants will receive a primary vaccination consisting of three doses of ACTACEL at either 2, 3, and 4 months of age or at 3, 4, and 5 months of age; or Wuhan DTaP and Act-HIB vaccines at 3, 4, and 5 months of age. All participants will receive a single booster dose at 18-20 months of age and will be followed up for one month after the last dose of study vaccine.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Haemophilus Influenzae Type B

Interventions

Type	Name	Description
BIOLOGICAL	DTaP//PRP-T Combined Vaccine	0.5 mL, Intramuscular
BIOLOGICAL	DTaP//PRP-T Combined Vaccine	0.5 mL, Intramuscular
BIOLOGICAL	DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine	0.5 mL, Intramuscular (each vaccine)

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-09-01
• Completion: 2011-12-01
• First posted: 2010-02-04
• Last updated: 2011-12-13

Locations

2 sites across 1 country: China